Clinical Trials in Australia / NCT05946941
Active, not recruiting
Phase 3
A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome
NCT05946941 · tracked via the Priya Life Science Australia tracker
Condition(s) studied
Sjögren's Syndrome
Investigational drug(s) / intervention(s)
Deucravacitinib →Placebo
Deucravacitinib: Specified dose on specified days
Placebo: Specified dose on specified days
Study summary
The purpose of this study is to assess the safety and efficacy of two doses of Deucravacitinib in adult participants with Active Sjögren's Syndrome.
Eligibility
Inclusion Criteria
* Satisfy the 2016 American College of Rheumatology/European League Against Rheumatism criteria for the classification of SjS at screening (score ≥ 4), and who have disease duration (from time of initial clinical SjS diagnosis) of at least 16 weeks prior to screening.
* Have moderate to severe SjS ESSDAI ≥ 5.
* Short duration of disease (≤ 10 years) before screening.
* A stimulated whole salivary flow (SWSF) ≥ 0.05 mililiters/minute (mL/minute).
* Positive anti-Sjögren's syndrome-associated antigen A (anti-Ro/SSA) at screening.
Exclusion Criteria
* Autoimmune disease other than SjS (for example, rheumatoid arthritis, systemic lupus erthrematosus \[SLE\], systemic sclerosis).
* Active fibromyalgia with pain symptoms or signs that would interfere with joint assessment or requiring adjustment in medication within the 3 months before screening to control symptoms; participants with fibromyalgia that is well controlled on stable treatment may otherwise be considered.
* Medical condition associated with sicca syndrome.
* Previous exposure to tyrosine kinase 2 (TYK2) inhibitors such as deucravacitinib or related compounds.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Primary outcome measure(s)
- Change from baseline in European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) Score at Week 52 — Baseline, Week 52
Trial sites (199)
| Facility | City | Region | Status |
|---|---|---|---|
| Local Institution - 0228 | Fullerton | California | |
| Local Institution - 0222 | La Palma | California | |
| Local Institution - 0218 | San Francisco | California | |
| Local Institution - 0203 | Santa Monica | California | |
| Local Institution - 0067 | Denver | Colorado | |
| Local Institution - 0049 | Clearwater | Florida | |
| Local Institution - 0226 | Cooper City | Florida | |
| Local Institution - 0223 | Sarasota | Florida | |
| Local Institution - 0140 | Augusta | Georgia | |
| Local Institution - 0229 | Lawrenceville | Georgia | |
| Local Institution - 0174 | Skokie | Illinois | |
| Local Institution - 0016 | Kansas City | Kansas | |
| Local Institution - 0017 | Baton Rouge | Louisiana | |
| Local Institution - 0125 | Monroe | Louisiana | |
| Local Institution - 0187 | Baltimore | Maryland | |
| Local Institution - 0173 | Boston | Massachusetts | |
| Local Institution - 0131 | Eagan | Minnesota | |
| Local Institution - 0138 | Summit | New Jersey | |
| Local Institution - 0009 | Albuquerque | New Mexico | |
| Local Institution - 0184 | Mineola | New York | |
| Local Institution - 0224 | Salisbury | North Carolina | |
| Local Institution - 0130 | Duncansville | Pennsylvania | |
| Local Institution - 0022 | Jackson | Tennessee | |
| Local Institution - 0144 | Allen | Texas | |
| Local Institution - 0227 | Katy | Texas | |
| Local Institution - 0175 | Plano | Texas | |
| Local Institution - 0133 | Seattle | Washington | |
| Local Institution - 0189 | Spokane | Washington | |
| Local Institution - 0050 | San Isidro | Alabama | |
| Local Institution - 0100 | CABA | Buenos Aires | |
| Local Institution - 0003 | Ciudad Autonoma de Buenos Aires | Buenos Aires | |
| Local Institution - 0019 | Quilmes | Buenos Aires | |
| Local Institution - 0026 | San Miguel de Tucumán | Tucumán Province | |
| Local Institution - 0137 | CABA | Argentina | |
| Local Institution - 0109 | City of Buenos Aires | Argentina | |
| Local Institution - 0061 | Córdoba | Argentina | |
| Local Institution - 0120 | Woodville South | South Australia | |
| Local Institution - 0117 | Graz | Austria | |
| Local Institution - 0087 | Vienna | Austria | |
| Local Institution - 0172 | Ghent | Belgium |
+ 159 more sites — see the full list on the official registry below.
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05946941 on ClinicalTrials.gov ↗ ← All trials in Australia